Assessment of Body Image in Patients With Rheumatoid Arth... | NCT00832910

Studies
Assessment of Body Image in Patients With Rheumatoid Arthritis

NCT00832910

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Jan 30, 2009Estimated

Enrollment

82Actual

Phase

Not provided

Conditions

Body Image
Rheumatoid Arthritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Actual

First Submitted Date

Jan 29, 2009

First Submission Date that Met QC Criteria

Jan 29, 2009

First Posted Date

Jan 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2009

Last Update Posted Date

Jan 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem, function and quality of life.

Detailed Description

Methods: Forty-three RA patients and thirty-nine control patients between 18 and 70 years were evaluated. The RA group was made up of individuals with a diagnosis of RA and the control group was made up of individuals from the community, paired for gender, age and body mass index. The patients were assessed with regard to body image (Body dysmorphic disorder examination (BDDE)), self-esteem (Rosenberg self-esteem scale), function (Health assessment questionnaire (HAQ)) and quality of life (Short form-36 (SF-36)).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

82Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Dysmorphic Disorder Examination		baseline

Secondary Outcomes

Measure	Description	Time Frame
Short Form - 36		baseline
Health assessment questionnaire		baseline
Rosenberg self-esteem scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The RA group included patients between 18 and 70 years of age, of either gender, with an established diagnosis of RA based ACR criteria and belonging to functional classes I, II and III. The control group was made up of individuals from the community paired for gender, age and body mass index with RA group.

Exclusion Criteria:

Individuals with fibromyalgia, neurological disease, psychiatric disorders or other severe co-morbidity were excluded from the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Rheumatoid arthritis in study group
Community sample in control group

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jamil Natour, Professor	Federal University of São Paulo	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Rheumatoid Arthritis group1		This group had patients with rheumatoid arthritis
2